Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial

Official record

Identifier

NCT06802172

Recruiting locations

country

United States

Interventions studied

Time-restricted eatingQuestionnaire AdministrationBiospecimen CollectionHealth coaching

Lead sponsor

Fred Hutchinson Cancer Center

Target enrolment

100 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Jan 31, 2025

Last updated on the registry

Jul 29, 2026

Age

21 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Male or female
* Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC
* Age≥21 years
* Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)
* Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)
* Histologically or cytologically confirmed solid tumor (adjuvant)
* BMI≥18.5 kg/m2
* Plan to receive neoadjuvant or adjuvant therapy
* Planned duration of neoadjuvant or systemic adjuvant therapy for \>3 months to allow sufficient time to assess impact of intervention
* Must have capacity to give informed consent
* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
* Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment
* Score of \< 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score \>5, have clearance from dietitian

Exclusion Criteria:

* History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)
* Allergic reaction to any of the treatment agents
* Any prior pelvic radiotherapy
* Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy
* History of GI perforation ≤12 months prior to enrollment
* History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)
* Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period
* History of uncontrolled CHF defined as NYHA Class III or greater
* Pre-existing grade ≥3 neuropathy
* Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment
* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
* Pregnant or breastfeeding
* Currently perform overnight shift work \>1 day/week
* Strictly adhering to a \<10-hour eating window on most days
* Severe psychiatric, cognitive, or substance misuse disorders or social conditions that would interfere with adherence to study procedures.

Indexed under

Colorectal Cancer